Description

Duloxetine-D3 Hydrochloride is a stable isotope-labeled analog of the widely used pharmaceutical agent duloxetine, where three hydrogen atoms are replaced by deuterium. This compound is an essential internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical researchers, clinical laboratories, and contract research organizations (CROs) engaged in drug development and therapeutic drug monitoring.

Application

• Bioanalytical Reference Standard: Serves as a primary internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of duloxetine in biological matrices like plasma, serum, and urine.
• Pharmacokinetic Research: Enables accurate measurement of absorption, distribution, metabolism, and excretion (ADME) profiles of duloxetine during preclinical and clinical trials.
• Metabolite Identification & Studies: Used in metabolite profiling and structural elucidation to understand the metabolic pathways of duloxetine.
• Clinical Laboratory Testing: Supports therapeutic drug monitoring (TDM) and forensic toxicology analyses requiring high specificity and sensitivity.
• Method Development & Validation: A cornerstone for developing, optimizing, and validating robust analytical methods in compliance with GLP and GCP guidelines.
• Quality Control in Manufacturing: Can be utilized in the quality control processes for duloxetine active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Item	Details
Product Name	Duloxetine-D3 Hydrochloride
CAS No.	1188266-11-6
Molecular Formula	C18H16D3NO • HCl
Molecular Weight	302.83 g/mol (for free base C18H16D3NO)
Synonyms	(+)-(S)-Duloxetine-D3 Hydrochloride; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine-D3 Hydrochloride; LY248686-D3 Hydrochloride; Cymbalta-D3 Hydrochloride; (S)-Duloxetine-D3 HCl; Deuterated Duloxetine Hydrochloride; Duloxetine Internal Standard
EINECS	Contact for details

Quality Control

Our Duloxetine-D3 Hydrochloride is manufactured under strict quality systems to ensure it meets the exacting standards required for analytical research. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, isotopic enrichment, and analytical results from techniques such as HPLC, NMR, and MS. We ensure compliance with relevant industry standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.